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The FDA's attitude will be crucial to the willingness of drugmakers to adopt personalized medicine and its wider application, writes Henry I. Miller, the founding director of the FDA Office of Biotechnology. Huge development costs could be imposed by the regulatory demand for extensive clinical trials to prove new drugs' safety as well as the need to develop biomarkers to go with these drugs, he writes. Furthermore, the diminished revenue potential may in the end become unsustainable for drugmakers, he writes.

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The budget proposed by the White House would affect drugmakers, wealthier seniors and post-acute care providers to achieve approximately $402 billion in savings in health care over the next 10 years. The budget would limit the price Medicare Part D plans could pay for drugs, increase means testing for Medicare, and reduce some payments to skilled nursing facilities and other post-acute care providers. Research advocacy groups said that relatively small increases for the NIH and FDA would not go far enough to restore past cuts.

Bayer's experimental drug riociguat won two orphan-drug designations from the FDA as a treatment for chronic thromboembolic pulmonary hypertension and as a treatment for pulmonary arterial hypertension.

Europe's second-highest court ordered the European Commission to pay DuPont Pioneer legal costs for delaying the approval of the latter's insect-resistant biotech maize. The European Commission failed to send a proposal to the EU Council of Ministers to approve the cultivation application and instead asked the European Food Safety Authority to provide new opinions on safety, the court found. "The Commission cannot, in a dilatory manner, repeatedly request opinions from EFSA pending the arrival of new scientific data and thereby justify its failure to submit the proposal to the Council," the court ruled.

The CDC is best suited to spearhead efforts in combating fraudulent and substandard tuberculosis treatments, American Enterprise Institute resident scholar Roger Bate writes. The agency should collaborate with the World Bank and the State Department's Office of Global Health Diplomacy to help drugmakers, governments and law enforcement curb the production of substandard treatments and fortify drug supply chains, Bate writes. Furthermore, producers of deadly counterfeits should be prosecuted.

The FDA asked Amgen to revise labels for Aranesp, Epogen and Procrit to include warnings that would further limit the anemia drugs' use in cancer patients, including those undergoing chemotherapy. Amgen will notify patients and doctors about the changes, which the company said were consistent with its expectations. Johnson & Johnson, which markets Procrit, said it will work with the FDA to implement the updated label.